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Track 1 Session 3: Challenges and Opportunities in Generics
Session Chair(s)
Sonica Sachdeva Batra, DrMed
Associate Vice President Enterprise Medical Head- Regulatory Solutions
Indegene, India
Generic companies frequently face challenges on signal management, which may impact updates to product information related to safety concerns especially when these originate externally. Competent authorities’ expectations are similar for innovative and generic marketing authorization holders in respect to the signal management and label changes. Based on the regulations and information received from the authorities “sufficient evidence” is needed for safety variations for generics, as well as for the innovative products. However, in practice signals submitted by the generic MAH many a times face rejection or are placed on hold on the grounds of “insufficient evidence”, in particular when the reference product label doesn’t include the respective safety topic.
Speaker(s)
Generics MAHs: Challenges in Managing Signals and Labelling Changes
Pooja Khattar
Sandoz, India
Medical Safety Team Lead
Generic Label Management
Amrit Gill
Sanofi, United States
Global Head – CHC, Consumer Healthcare Division
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